ICH ( Internatio nal Con ference on Harm on ization of Tech nical Requirements for Registration of Pharmaceuticals for Human Use)人用约物注册技术要求国际协调会Q10:药品质量管理体系(PQS),基于QMS (质量管理休系)而來，最合适的指南 应该是ICH的Q10oQ9:质量风险管理Q8:跖物开发自动化生产规范 GAMP5 (Good Automated Manufacturing Practice)由 ISPE(lnternational Society For Pharmaceutical Engineering 国际制药工程协会创立弔 1980年，是致力丁•培训制药领域专家并提升制药行业水准的世界最大的非盈利性组织之一) 的GAMP论坛(GAMP Forum)组织编写发布的关丁•制药企业计算机化系统的综合性指南纠正和预防措施 CAPA (Corrective Action & Preventive Action)超出标准的可疑结果OOS (out of specification)质量管理 QM (Quality Management)质量保证 QA (Quality Assurance)质量控制 QC (Quality Control)牛产管理 PM (Production Maanagement)工程设备管理 EM (Engineer Equipment Managemant)销售管理 MS (Maragement Of Sales)行政人员管理 AP (Administration and Personael Managemeht)丄艺验证 PV (Process Validation)设备验证 EV (Equipment Validation)工艺规程 PP (Process Procedure)质量标准 QS (Quality Management)物料管理 MM (Materid Management)原料管理 RM (Raw Material Management)辅料管理 EM (Excipient Management)质量标准 QS (Quality Standard)增补和修订 A. A. A Addition and Amendments空调器 AC Air Conditioner药物不良反丿M ADR Adverse Drug Reaction食品与药品官员协会(美国)AFDO Association of Food and Drug Officials 接受 ACC Accept合格质量标准 AQL Acceptable Quality Level简化的新药申请 ADNA Abbreviated New Drug Application物料清单 BOM Bill of Material原料药 BPC Bulk pharmaceutical Chemiclls牛•物制品评价与研究中心 CBER Center for Biologies Evaluation Research菌落形成单位 CFU Colony Forming Unet药品管理档案DMF Drug Master File药物评价与研究中心 CDER Cemter for Drug Evaluation amd Research企业识另ij (形象)Cl Corporate Identity (Image)清洗 CIP Cleaning in Place消费者安全调查员 CSI Consumer Safety Insepctor 莊线清洗程序 CLP Cleaning Line Procedure 缺陷作用水平 DAL Defect Action Level 管制药品管理 DEA Drug Enforcement Adminestration 文件系统 DS Documentation Systim食品与药品管理局(美国)FDA Food and Drug Administration 关贸总协会 GATT General Agreemernt on Tariffs and Trade 药品牛质量管理规范 GMP Good Manufacturing Practice 药品临床实验管理规范GCP Good Clinical Practice 实验室管理规范 GLP Good Laboratory Practice 药品商业质量规范GSP Good Supply Practice 药品零业质量管理规范GRP Good RaTAIL Practice 药材牛产管理规范 GAP Good Agriculture Practice 验证管理规范 GVP Good Validation Prctice 药品使川规范GUP Good Use Practice国际标准化组织 ISO Intematonal Organization for Standardization 谅解备忘录 MOU Memorandum of Understanding生产记录用表格PF Porduction File非处方药品 OTC Over the Counter (Drug) 产品许i J中请 PLA Product License Application 质量管理程序 QMP Quality Management Procedure 国家药品监督管理局SDA State Drug Administration 标准管理程序 SMP Standard Managmert Procedure 标准操作程序 SOP Standard Operating Procedure 全面质量管理 TQC Tatal Quality Control 美国药典 USA Uneted States Pharmacopeia 生产管理中的术语 系统:system起始原料:starting material物料：material料平衡:reconcilination批：batch or lot扌比号：batch number (lot number)批档案：batch records文件:doocument标准操作规程：standard operating processsing工艺规程:master for processing纯化力＜：puritied water工艺用水：water for processing蒸憎水:distilled water去离子水：deionized water注身寸川水：water for injection无菌：sterile灭菌：sterlization(sterilise)无菌制剂:sterile product ?(preparation,dosage from) 非无菌制剂:non-sterile product状态标志:status mark (labet)中间产品：in termediate product制造：manufacture 带包装品：bulk product成品：finished product》A性药物纟11.分：active pharmaceutical ingredient理论产量：theoretical yield质量管理中的术语待验:quarantine控制点：control point质量保证：quality assurance质量控制：quality control质量管理：quality management质量体系：quality system质量监督:quality surveillance规格标准:specification生产过程中控制：in-process control返工：reprocessing退货：retured product拒收：rejected交叉污染：cross contamination放行：released质量要求:quality requirement质量管理体系：quality management systemnJ追溯性：traceability合格(符合)：conformity不合格：non conformity预防措施：preventive action质量手册：quality manual计量确认:metrological confirmation验证术语：验证:validation空调净化系统：HVAC( heating ventilation and air conditioning)起泡点实验：bubbling point挑战性试验：challenge test最怎状况：worst case不合格限：edge-of-failure严整方案:validation protocol清洗：CIP(cleaning in place)灭菌:SIP(sterilization in place)预确认:pre qualification安装确认:IQ(instalation qualification)运行确认：OQ(operational qualitification) 性能确认：PQ(performance qualificantion 产品验证：PV(product validation)工艺验证：process validation 前验证：prospective validation 同步验证：concurrentvalidation 回顾性验证：retrospective 认证：certification具他术语：管理体系：management system纽织结构：organizational structure扌旨南：guideline销伟许 | J证：marketing authorization计算机系统：computerized system生物反应器：biogenerator生物试剂:biological agents细胞库系统：cell bank system匸细胞库：master cell bank工作细胞脸：working cell bank细胞培养：cell culture种子库:seed lot」［种子库：master seed lot工作种子库：working seed lot外源牛物体：exotic organism放射性药品：radio pharmaceutical原植物(植物药)crude plant(vegetable drug)药用植物:medicinal plant草药品：herbal pharmaceuticalOn the Road推荐阅读：CAPA (Corrective Action & Preventive Action)纠正 2010・08・09 19:25:00OOS 和偏差 2010・07・09 15:27:01车间标识中英对照2010-08-16 15:37:56GMP文件管理常用的英文缩写2009-06-08 11:23:40。